Senior Regulatory Affairs Project Manager
Job Description
Job Title
Senior Regulatory Affairs Project Manager
Job Description
Job title: Senior Regulatory Affairs Project Manager
Your role:
Key Areas of Responsibility
Quality Culture/Process Improvement - Identify areas for improvement for efficiency and compliance in the internal processes, work instructions, and forms and apply technical expertise to process improvement efforts. May lead or participate on process improvement teams to affect changes at a local or cross business unit level.
Training - Maintain technical expertise in core job functions including all applicable QSPs, WI, Forms, Philips training, and regulatory body requirements.
Regulatory Proficiency - Maintain expertise in the interpretation of domestic and international regulations and laws as they apply to the licensing, registration, manufacture, shipping, and sale of assigned medical devices, with a special focus on mature markets: USA, Canada, and EU.
Job FunctionmQMS Support and CD Material Controls Support
- Lead DCO process for procedure release after final procedures are drafted. Applicants must be able to understand and follow complex processes and communicate effectively to ensure all required deliverables are in place prior to Quality System Procedure releases.
- Help validate processes through redline reviews, compliance mapping, and process simulation. Applicants must possess some Regulatory knowledge to be able to effectively review draft procedures, provide valuable feedback, and map draft procedures to applicable Standards and Regulations.
- Map roles to processes within completed procedures for Regulatory QSD's. Applicants must have good organizational skills and attention to detail.
- Help place and lift Regulatory Blocks per the CD Material Control Plan. Applicants must have good problem-solving skills to be able to investigate exceptions and resolve issues surrounding new process.
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.Onsite roles require full-time presence in the company's facilities.
Field roles are most effectively done outside of the company's main facilities, generally at the customers or suppliers locations.
Indicate if this role is an office/field/onsite role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.- Learn more about .
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If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .